CONVENTION UPDATE: GE Animals Challenges and Solutions

By Val GiddingsThe emerging field of genetically engineered (GE) animals faces challenges and opportunities for success. At BIO’s International Convention, this session took a look at some of the current and future challenges.

Greg Jaffe, Director of the Biotechnology Project for Center for Science in the Public Interest (CSPI) was invited to participate in the panel discussion as CSPI has always been supportive of animal biotechnology, but emphatic that an appropriate regulatory system be in place.

Jaffe agrees the applications of the technology are promising, but the industry needs to do a better job of educating the public and making them comfortable, and perhaps broader stakeholder discussion need to take place.

Mimi Riley of the University of Virginia Law School Speaker spoke on the relationship of U.S. law, biotechnology and ethics, and disagrees with Jaffe that we need more regulation. The existing law for GE animals is adequate. But Riley thinks policymakers should become more involved. There is a need for national discussion but not a national yelling match.

Larisa Rudenko, PhD, Senior Advisor Biotechnology, U.S. Food and Drug Administration (FDA) has been working on the issue of animal biotechnology for more than two decades. She offered the government perspective, and assured the group that FDA does have adequate authority to regulate GE animals.

Some of the challenges for FDA are the very same as some of the challenges for industry: Consumer awareness of the technology and education, communications among stakeholder groups, international outreach, etc.

Over the past year, FDA has received some criticism about its new regulatory guidance governing GE animals in regards to transparency, but what does that mean? FDA is transparent about the nature of the process and the requirements. FDA is transparent about the nature of their analysis and the basis of their conclusions. In regards to criticism over the NAD (New Animal Drug) process, FDA has posted on its website a great deal of information on the drug approval process.

FDA acknowledges that challenges for technology include funding, public acceptance, effective communications from unbiased, credible sources of information. We can’t “overpromise” the technology. It is another tool in the toolbox. And people need to have faith in the regulatory system.

To address some of these concerns, the government has an appropriate role to play in communicating with the public, ensuring a robust regulatory system, acting as an unbiased and credible source of information, and improving stakeholder interaction.

As the session called for a discussion of not just “challenges,” but also “solutions,” Rudenko offered the following:

Keep learning, avoid polarization, and learn from mistakes – our own and others.

Giddings is a genetics PhD and biotech consultant with nearly 30 years regulatory, media, and policy experience. He was a Vice President for BIO Food & Agriculture from 1997 to 2006. He can be reached at LVG@prometheusAB.com.